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I hope my long friends on this board are taking advantage of the baby being thrown with the bath water. Take advantage of the bargain Mr. Market is giving us.
LOL. I dictated a lot of it
Biotechinvestor1:
I hope you didn't type this on your phone!
It might be good for you to educate yourself a bit before making such absolute forecasts.
Here are some examples of patent disputes in the pharmaceutical industry where one company acquired its opponent, showcasing how such conflicts can lead to strategic acquisitions:
1. **Pfizer and Wyeth** - **Dispute**: Pfizer and Wyeth had overlapping interests and competitive tensions in the pharmaceutical market, particularly around blockbuster drugs like Lipitor (Pfizer) and Effexor (Wyeth). While not always directly litigating over patents, their rivalry included intellectual property skirmishes related to drug formulations and market exclusivity. - **Acquisition**: In 2009, Pfizer acquired Wyeth for $68 billion. This move came as Pfizer faced the looming patent expiration of Lipitor, its top-selling cholesterol drug. By acquiring Wyeth, Pfizer gained access to Wyeth’s patent portfolio, including vaccines like Prevnar, neutralizing potential disputes and diversifying its revenue stream ahead of generic competition.
2. **Sanofi and Genzyme** - **Dispute**: Sanofi and Genzyme were entangled in patent-related competition over rare disease treatments, notably enzyme replacement therapies. Genzyme held key patents for drugs like Cerezyme (for Gaucher disease), and Sanofi, seeking to expand into the lucrative rare disease market, faced potential IP conflicts. - **Acquisition**: In 2011, Sanofi acquired Genzyme for $20.1 billion after a contentious negotiation. The acquisition resolved any brewing patent disputes by bringing Genzyme’s IP, including patents for orphan drugs, under Sanofi’s control, strengthening its position in biotechnology and specialty pharmaceuticals.
3. **Gilead Sciences and Pharmasset** - **Dispute**: Pharmasset developed sofosbuvir, a groundbreaking hepatitis C drug, and held critical patents that Gilead needed to dominate the antiviral market. Prior to the acquisition, there was potential for patent disputes as Gilead worked on similar compounds, risking infringement or licensing battles. - **Acquisition**: In 2012, Gilead acquired Pharmasset for $11 billion. This acquisition preempted any patent litigation by securing Pharmasset’s IP, including sofosbuvir (later marketed as Sovaldi), which became a multi-billion-dollar drug and solidified Gilead’s leadership in hepatitis C treatments.
4. **Merck and Schering-Plough** - **Dispute**: Merck and Schering-Plough had a history of patent tensions, particularly over cholesterol-lowering drugs. Schering-Plough’s Zetia and Merck’s Zocor were part of a competitive landscape where patent challenges and licensing disagreements loomed as generics approached. - **Acquisition**: In 2009, Merck acquired Schering-Plough for $41 billion. The merger resolved potential patent conflicts by combining their portfolios, including the lucrative Zetia/Vytorin franchise, and allowed Merck to bolster its cardiovascular offerings while avoiding prolonged legal battles.
5. **Roche and Genentech** - **Dispute**: Before its full acquisition, Roche and Genentech had a complex relationship involving patent licensing and disputes over biotech innovations, notably around monoclonal antibodies and cancer therapies like Avastin and Herceptin. Partial ownership by Roche didn’t fully eliminate IP friction. - **Acquisition**: In 2009, Roche completed its acquisition of Genentech for $46.8 billion, having previously held a majority stake. This full takeover ended any remaining patent disputes by integrating Genentech’s extensive biotech patent portfolio, enhancing Roche’s dominance in oncology and biologics.
These cases illustrate a recurring pattern in the pharmaceutical industry: patent disputes often drive companies to acquire their rivals, securing valuable intellectual property, resolving legal uncertainties, and gaining a competitive edge in high-stakes markets.
Some more non-pharma examples:
1. **Nokia and Alcatel-Lucent** - **Background**: Nokia and Alcatel-Lucent were embroiled in multiple patent disputes over telecommunications technologies, including mobile network infrastructure and related innovations. These disputes spanned several years and involved complex intellectual property litigation across various jurisdictions. - **Acquisition**: In 2015, Nokia acquired Alcatel-Lucent for approximately $16.6 billion. The acquisition gave Nokia access to Alcatel-Lucent’s extensive patent portfolio, which included around 29,000 patents, significantly strengthening Nokia’s position in the telecommunications market. The move was seen as a way to resolve ongoing disputes and consolidate resources in a competitive industry.
2. **Google and Motorola Mobility** - **Background**: In the early 2010s, Google faced indirect patent disputes with Motorola Mobility, which was involved in litigation with competitors like Apple and Microsoft over smartphone technologies. Motorola held a valuable portfolio of patents related to mobile devices, which were critical in the escalating "smartphone patent wars." - **Acquisition**: In 2012, Google acquired Motorola Mobility for $12.5 billion. A key motivation was to gain control of Motorola’s 17,000 patents and 7,500 pending patent applications, which Google could use to defend its Android ecosystem against legal challenges from rivals. While the disputes weren’t directly between Google and Motorola, the acquisition neutralized potential conflicts and bolstered Google’s patent defenses.
4. **Microsoft and Nokia (Mobile Division)**
- **Background**: Microsoft and Nokia had a complex relationship, including patent licensing agreements and disputes related to mobile technologies. Nokia had sued various companies over patent infringements, and while Microsoft wasn’t a direct target, the broader mobile patent landscape created tensions as Microsoft developed its Windows Phone platform with Nokia as a partner. - **Acquisition**: In 2014, Microsoft acquired Nokia’s mobile phone division for $7.2 billion. This deal included a 10-year patent licensing agreement and access to Nokia’s vast patent portfolio, resolving any lingering intellectual property uncertainties and integrating Nokia’s assets into Microsoft’s mobile strategy.
5. **Broadcom and Qualcomm (Attempted Acquisition)** - **Background**: Broadcom and Qualcomm were locked in a series of patent disputes over semiconductor and wireless technologies. These disputes escalated into a hostile takeover bid when Broadcom attempted to acquire Qualcomm in 2017-2018, partly to gain control over Qualcomm’s extensive patent holdings. - **Outcome**: Although Broadcom did not succeed in acquiring Qualcomm (the deal was blocked by the U.S. government on national security grounds in 2018), this case illustrates how patent disputes can drive acquisition attempts. Had the acquisition succeeded, it would have ended their legal battles by consolidating their intellectual property under one entity.
These examples demonstrate how patent disputes can serve as a catalyst for acquisitions, allowing the acquiring company to resolve legal conflicts, secure valuable intellectual property, and strengthen its market position. In each case, the acquisition either directly or indirectly addressed the underlying patent issues by bringing the opponent’s assets under the acquiring company’s control.
This will never happen.
For Merck to buy HALO, it would signal that their little "spin-off" S. Korean company didn't work out.
Alteogen would be toast.
Yeah, sorry about that. I saw something that said futures were up and I should have been more careful in checking it out.
NASDAQ futures are down over 800 pts as of this writing
Why all the negative after hours trading when the future indexes are all positive?
Merck is choosing between signing a deal with Halozyme for MDASE or risking a dealy in launch of Keytruda SC (i.e. loss of market share to BMY's opdivo SC) or even worse yet a delay in launch followed by a loss in the courtroom for patent infringements.
There is a 3rd option. Merck could buy halozyme out. No risk of a launch delay or unfavorable court ruling and no need to pay MDASE royalty if Merck owns halozyme. At a 2025 PE of 13 and PEG of 0.45, halo is such a bargain https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios
And once Merck owns halozyme, it will be BMY that would be paying Merck for Enhanze royalties (for Opdivo SC) for a longtime to come.
"The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years,..." The article is from Seeking Alpha. This may not affect Halo, though.
"Genmab (GMAB) ADRs traded lower on Tuesday after Bernstein downgraded the Danish biotech to Underperform from Market Perform, arguing that its stock has yet to fully reflect the upcoming patent cliff for the company’s blood cancer therapy Darzalex, marketed with J&J (JNJ).
The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years, can lead to a threefold drop in GMAB’s group revenue in 2030-2040 under his base case, Bernstein analyst Justin Smith wrote.
Despite disappointing news about JNJ’s decision to opt out of HexaBody-CD38, a potential successor to Darzalex, Genmab (GMAB) shares have yet to fully discount the impact from the upcoming patent cliff, Smith added, citing his base case 2025–2029 EPS estimates for GMAB."
According to AI overview:
Darzalex (daratumumab) faces a loss of market exclusivity, with its patents expiring in 2027 in the US and 2026 in the EU, potentially leading to biosimilar competition.
Here's a more detailed breakdown:
Patent Expiration:
Darzalex's key US patents are set to expire in 2027.
The drug's patents are protected until 2026 in both the US and EU.
However, several other patents extend its exclusive protection until 2035.
Orphan Drug Exclusivity:
Darzalex has regular MP and ODE for the treatment of multiple myeloma, both of which will expire in May 2026.
Potential for Biosimilars:
The expiration of Darzalex's patents could pave the way for biosimilar versions of the drug to enter the market.
Darzalex Faspro:
Darzalex Faspro, a subcutaneous formulation of Darzalex, also has patents that are set to expire in 2035.
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.
The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.
The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Halozyme's announcement of Bristol Myers Squibb receiving a positive CHMP opinion for subcutaneous Opdivo utilizing ENHANZE® technology represents a significant commercial advancement for Halozyme's drug delivery platform. This recommendation encompasses multiple solid tumor indications and builds upon the December 2024 FDA approval of Opdivo Qvantig in the U.S.
This development validates Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) platform as a facilitator for subcutaneous administration of traditionally intravenous biologics. For Halozyme, each commercial implementation of ENHANZE typically generates tiered royalties on net sales plus potential milestone payments, though specific financial terms for this particular agreement weren't disclosed.
The subcutaneous formulation offers substantial clinical advantages including reduced administration time compared to IV infusions, potentially expanding Opdivo's competitive positioning against rival checkpoint inhibitors. With European Commission approval expected by June 2, 2025, this represents a near-term potential revenue catalyst for Halozyme.
Bristol Myers Squibb's Phase 3 CheckMate -67T trial provided the efficacy and safety data supporting this recommendation, suggesting the subcutaneous formulation maintained Opdivo's therapeutic profile while offering administration benefits. For Halozyme, this advancement bolsters its technology's commercial viability in high-value oncology applications while potentially reducing healthcare resource utilization – a key selling point for future ENHANZE partnerships.
https://www.stocktitan.net/news/HALO/halozyme-announces-bristol-myers-squibb-received-positive-chmp-57liwjmgzun2.html
AI (Grock):
"Probability Assessment:- Base Case (60%): Merck opts for a licensing deal to secure the 2026 launch and avoid risk. This assumes the PGR process or litigation threat creates enough uncertainty to favor settlement, and Halozyme offers reasonable terms. The pharma industry’s tendency to settle high-stakes disputes supports this.- Alternative Case (40%): Merck fights and wins, either invalidating the patents or proving non-infringement. This hinges on strong PGR outcomes or a favorable court ruling, bolstered by Merck’s resources and Alteogen’s enzyme differentiation.
Balancing these, I’d assign a 65% probability that Merck signs a licensing agreement with Halozyme. The edge comes from Merck’s need for speed and Halozyme’s licensing track record, though Merck’s aggressive PGR strategy introduces notable uncertainty. If the PTAB denies PGR institution (mid-2025) or Halozyme pushes hard on litigation, this could shift toward a deal; if Merck gains early wins, it might drop below 50%. For now, 65% feels like a reasoned bet on pragmatism prevailing."
52 week low for the XBI.
We're(HALO longs) doing pretty good.
We are almost into the second quarter of 2025 and still waiting for the HVAI that Helen had forecasted for 2023.
Is the impressive share price action due to the anticipation of 1) HVAI deal, 2) phenomenal valuations (PE/ PEG ratios and growing earnings and profit margins) or 3) anticipation of a win against Merck?
I think the former 2 reasons are more likely.This week we had a couple of articles that made me think a halozyme win might not be such a slam dunk (I still think that halo is more likely to win) and yet stock is acting well.
Great article. Wish I could understand it.
BRIEF-Merck Says FDA PDUFA Date For Subcutaneous Pembrolizumab Set For Sept 23
"While Merck and Alteogen could face a potential patent challenge from biotech Halozyme Therapeutics (HALO.O), over the enzyme, Merck said it will not delay the launch of the drug.
"We believe we have a very strong position relative to the claims from Halozyme," Merck's Monahan said."
https://www.reuters.com/business/healthcare-pharmaceuticals/merck-plans-us-launch-subcutaneous-version-keytruda-october-1-2025-03-27/
https://www.markmanadvisors.com/blog/2025/3/27/w7lv67t4yzfvbmrph1blwz17mkbee0
It's hard to say who will win the post-registration dispute but even if Merck wins that round, that will take care of only 7 of more than 100 applicable patents that Merck is infringing.
Does anyone have a copy of halozyme's 2012 priority application for patent 11,655,600?
Howee, that was a little early for your April Fools joke. LOL!
Because I originally thought that Merck and halo were testing Enhanze in the past. It looks like that wasn’t the case. It was pegph20 and not Enhanze.
Why would you post a 10 year old article?
I'm totally confused??????
It is certainly exhibiting strength on a day where xbi, ibb and big pharma were all very weak. And
alteogen has dropped 18% in the past 5 days.
Right, 2015. Disregard.
This is a 10 year old article ??
That is weird. HALO is sponsoring it.
Looks like wasn’t Enhanze but Pegph20.
Another strong finish with high volume. No option expiry to explain this one.
It's Dr. Torley.
Enjoy the gift from Mr. Market. Buying dips equally enjoyable as hitting 52 week and all time new highs.
Congratulations biotechinvestor 1
Congratulations Ms. Torley!!
I blinked and missed it. Maybe it will come around again today. Love these numbers!!!!!
There it is! New all time high. :)
Well, since they had the whole week to release the news, it does suggest that they tried to keep it under the radar. Also, I find the wording a bit odd -- very terse and a bit ambiguous. "His decision to retire from the company" suggests that he is going to stop working but not necessarily. Did he leave to pursue other opportunities or not?
Still, it's probably not something to be very concerned about.
Not strange at all. No one will know what happened here whether voluntary or involuntary but he clearly had success in the position. Be interesting to see his replacement.
Is it strange for HALO to put out an 8-k on Friday, March 21 at 4:03 pm, after the market closed for the week, regarding the March 17 retirement of Michael LaBarre?
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) On March 17, 2025, Michael J. LaBarre, Senior Vice President, Chief Technical Officer of Halozyme Therapeutics, Inc. (the “Company”) notified the Company of his decision to retire from the Company, effective March 17, 2025. The Company thanks Mr. LaBarre for his many years of service and contributions to the Company’s ENHANZE® drug delivery technology.
Michael LaBarre Biography and Net Worth
Chief Technical Officer of Halozyme Therapeutics
Dr. LaBarre brings to Halozyme more than 25 years of experience across all aspects of biopharmaceutical research and drug development, including strong expertise in chemistry, manufacturing, and controls (CMC), regulatory strategy and product development. Dr. LaBarre joined Halozyme in 2008 and has held leadership positions in product development, alliance management, research, and regulatory affairs during that time. He is currently responsible for providing scientific and technical leadership across all Halozyme programs and is the lead expert on Halozyme’s ENHANZE® drug delivery technology.
Prior to Halozyme, Dr. LaBarre served as Vice President of Product Development at Paramount BioSciences, LLC, where he led CMC and research efforts for the product development programs within Paramount’s portfolio companies. Prior to joining Paramount, Dr. LaBarre served from 1995 to 2006 in various research and development positions at Biogen Idec (formerly IDEC before the merger with Biogen in 2004), where he supported numerous IND and BLA submissions, including those for the commercial products RITUXAN® and ZEVALIN®. Prior to IDEC, Dr. LaBarre spent two years at Vical, Inc. and he began his career at Hybritech in San Diego in 1992. Dr. LaBarre also taught chemistry laboratory for several years as an adjunct professor at Mesa Community College early in his career.
Dr. LaBarre received his B.S. in Chemistry from Southampton College of Long Island University and his Ph.D. in Chemistry from the University of Arizona.
What is Michael J. LaBarre's net worth?
The estimated net worth of Michael J. LaBarre is at least $11.11 million as of February 27th, 2025. Dr. LaBarre owns 173,756 shares of Halozyme Therapeutics stock worth more than $11,114,303 as of March 21st. This net worth approximation does not reflect any other investments that Dr. LaBarre may own. Additionally, Dr. LaBarre receives a salary of $843,890.00 as Chief Technical Officer at Halozyme Therapeutics.Learn More about Michael J. LaBarre's net worth.
How old is Michael J. LaBarre?
Dr. LaBarre is currently 60 years old. There are 2 older executives and no younger executives at Halozyme Therapeutics. The oldest executive at Halozyme Therapeutics is Dr. Helen I. Torley M.B. Ch. B., M.R.C.P., President, CEO & Director, who is 61 years old. Learn More on Michael J. LaBarre's age.
Well at least these program stock sales will be gone. I’ll bet the day end volume has something to do with options expiration.
In the past five days, Halo has traded up whereas Alteogen, Mrk and Azn have all traded down. It may be a coincidence but maybe someone knows something.
It's nice to see fundamentals and value win over nonsense and noise.
It's fun to look at some of the old posts and predictions. Late November and early December, our IH board permabears were at it again with their doom and gloom posts; one of them predicting that halo will be dropping to $30's.
Some of us pointed to the PE and PEG ratios as the north star and opined that halo will be trading back in the $60's EVEN WITHOUT A SINGLE NEW DEAL.
Here we are, no new deal announced yet and we are in mid $60's. The earnings are growing so fast that we are still trading at PEG of 0.5 and forward 2025 PE of 13.5 which are incredible bargains. Imagine how much higher we can go when a HVAI deal is announced.
In my opinion, Halo's strong performance also points to a sense of confidence by institutional investors that halo will prevail against Merck (either a licensing agreement is signed or Merck loses in court)
That was one strong last 5 minutes.
Huge volume to the upside going into the weekend.
Have a great weekend everyone.
That was a beautiful close with volume and conviction. :)
New all time highs! Will it be today? Will it be next week? Will Mr. Market give us a dip to load up more?
All 3 possibilities sound great to me.
Still an amazing bargain with the following valuation metrics: https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios ;
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http://www.halozyme.com
Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases.
The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
Products/Pipeline
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
The foundation of our capabilities is our recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a structural protein in the interstitial space. This temporary alteration provides an opportunistic window that allows the delivery of injectable biologics such as monoclonal antibodies, as well as small molecules and fluids. With our enzyme, many pharmaceuticals that would normally be injected intravenously (IV) can be administered subcutaneously (SC). This change in route of delivery may improve patient convenience, enhance pharmacokinetics, boost efficacy, extend the product lifecycle, and reduce cost, in addition to other attributes.
Four key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise consists of Insulin-PH20, which applies our PH20 enzyme to currently approved and marketed insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of tumor cells, and Chemophase, which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise, HTI-501, is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.
Our product development pipeline also includes three distinct partnered programs with two companies; Roche and Baxter BioScience for Enhanze technology, and a partnership with Baxter Medication Delivery for Hylenex, our FDA-approved drug. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the commercial stage. We utilize the cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.
Endocrinology
Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market.
We believe that the combination of our PH20 enzyme with existing, meal time insulin products such as regular insulin or a fast acting analog could lead to a best-in-class product that more closely mimics the release of natural insulin in the body. The results of a Phase 1 study, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.
Our first Phase 2 clinical trial with insulin began in October 2008 and enrolled Type 1 diabetic patients. Data presented from our Phase 1 trial showed that the administration of regular insulin and an insulin analog with our PH20 enzyme led to faster insulin absorption and more rapid effects than either insulin alone. Our Phase 2 trial is designed to demonstrate similar results in Type 1 diabetic patients. We hope to present preliminary Phase 2 results at the American Diabetes Association meeting in June. Additional clinical trials are planned in 2009.
ONCOLOGY
Hyaluronan (HA) is a component of the extracellular matrix that frequently accumulates in human cancers. The quantity of HA produced by the tumor cells directly correlates with increased tumor growth and metastasis and it has been linked with tumor progression and poor prognosis. Previous clinical trials of bovine hyaluronidase showed promise in enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in chemo-refractory patients. In animal studies the removal of HA from tumors with hyaluronidase has demonstrated improved survival, suppression of tumor growth, and enhanced efficacy of certain anti-cancer drugs. Chemotherapeutic agents may be able to better penetrate the tumor once the HA has been removed.
We have also observed significant reduction of tumor interstitial fluid pressure (IFP) following the administration of rHuPH20 in solid tumors grown in mice. Tumor interstitial pressure is widely believed to be an important factor limiting the access of cytostatic regimens to solid tumors. By digesting the HA gel, rHuPH20 may reduce IFP in the tumor and promote more effective delivery of chemotherapy throughout the tumor. This could potentially lead to better patient outcomes and increased survival.
Our PEGPH20 program utilizes pegylated hyaluronidase that allows for intravenous administration to degrade the HA that surrounds tumor cells. The Chemophase program applies the hyaluronidase enzyme along with mitomycin C directly into the bladder where the enzyme can hydrolyze the HA produced by the cancerous bladder cells. Unlike tumor cells, normal cells do not produce HA in this manner and appear not to be adversely affected by the enzyme.
We are investigating pegylated-rHuPH20, or PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors rich in hyaluronan, or HA. Pegylation refers to the attachment of polyethylene glycol to our rHuPH20 enzyme, which extends its half life from less than 30 seconds to more than 24 hours. Numerous solid tumors, including prostate, breast, pancreas, colon and non-small cell lung, accumulate HA that forms a halo like coating over the surface of the tumor cell.
In preclinical studies, PEGPH20 has been shown to remove the HA coating surrounding several tumor cell lines. Treatment of PC3 (a prostate cancer cell line that produces HA) tumor bearing mice with PEGPH20 as a single agent demonstrated approximately 70% tumor growth inhibition relative to controls. Repeat dosing with PEGPH20 produced a sustained depletion of HA in the tumor microenvironment. For tumor models that do not produce HA, the presence of PEGPH20 has no effect. An estimated 20% to 40% of certain solid tumors may produce HA.
Administration of the combination of PEGPH20 with docetaxel or with liposomal doxorubicin in HA producing animal tumor models produced a significant survival advantage for the combination relative to either chemotherapeutic agent alone. Therefore, based on these animal studies and other tests conducted by Halozyme, PEGPH20 may represent a potentially innovative treatment approach against tumors that produce HA.
PEGPH20 recently started its first Phase 1 clinical trial which will evaluate the agent over a range of doses. The study will enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 as a single agent twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be in each dosage cohort. The primary outcome measures of the study will be to evaluate safety and tolerability of PEGPH20 and to determine the recommended single agent Phase 2 dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity.
Chemophase is a chemoadjuvant we have investigated for possible use in the treatment of patients with superficial bladder cancer, which represents a smaller potential market than our other proprietary pipeline opportunities. The Chemophase program combines our PH20 enzyme with mitomycin C, a cytotoxic drug, for direct administration into the bladder immediately after transurethral resection of bladder tumors (TURBT), a standard surgical treatment for the disease. Many bladder tumor cells produce high quantities of HA and thus treatment to remove the HA coating could increase their exposure to mitomycin C. This may lead to a lower recurrence of the cancer and a better prognosis for patients.
In June 2008, we announced the interim results of a Phase I/IIa clinical trial in which the Chemophase combination treatment of mitomycin C plus rHuPH20 enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme. An ongoing safety trial involves the immediate post operative (IPOP) administration of PH20 and mitomycin directly into the bladder of patients after a TURBT procedure.
DERMATOLOGY
The foundation of our dermatology program is HTI-501, a human lysosomal proteinase that degrades collagen. It may be useful in the treatment of both medical and aesthetic dermatologic conditions such as cellulite, Dupuytren’s contracture and Peyronie’s disease. This pH sensitive enzyme demonstrates activity under mildly acidic conditions but shows no activity at normal physiologic pH. This attribute may be harnessed to exert control over the duration and location of the enzyme’s therapeutic activity.
Tests with HTI-501 in several animal models have produced encouraging results and our pre-clinical investigations of the enzyme will continue throughout 2009.
ENHANZE
Enhanze™ Technology, a proprietary drug delivery platform using Halozyme’s first approved enzyme, rHuPH20, is our broader technology opportunity that can potentially lead to partnerships with other pharmaceutical companies. When co-formulated with other injectable drugs, Enhanze Technology may facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin.
Molecules as large as 200 nanometers may pass freely through the extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of our Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics. We are seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc. In September 2007, we signed our second Enhanze Technology partnership with Baxter Healthcare Corporation and Baxter Healthcare S.A.
HYLENEX
Full prescribing information is available below or at www.hylenex.com
Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received approval of our Hylenex NDA in December 2005.
Hylenex may facilitate subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as EASI. Importantly, EASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance. Over 1.1 million subcutaneous fluid infusions are performed per year with hospice patients alone (Source: Company estimates based on National Hospice and Palliative Care Organization data, 2001). In addition, over 500 million infusion bags are utilized annually in the United States, some of which could potentially convert to EASI using Hylenex, giving rise to additional market potential (Source: B. Braun, 2003).
During January 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, which was designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer’s solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters.
During October 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, which was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 12 evaluable patients who received Sub-Q infusions.
For full prescribing information, visit www.hylenex.com or www.baxter.com.
CUMULASE
Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval and we filed our 510(k) application during September 2004.
We received FDA clearance in April 2005. We launched Cumulase in the European Union and in the United States in June 2005. We believe the total ICSI market consisted of an estimated 500,000 intracytoplasmic sperm injection cycles worldwide in 2005 (Source: CDC, 2001; ESHRE, 2002).
Visit www.cumulase.com for more information.
Informative Links
http://www.nasdaq.com/asp/Holdings.asp?FormType=Institutional&page=holdingssymbol=HALO&selected=HALO
(Institutional Holdings)
http://www.cnbc.com/id/15837275?q=HALO
(Big Block Holders from CNBC)
http://www.sec.gov/edgar/searchedgar/companysearch.html
(SEC filings search from SEC.gov Edgar)
http://www.nasdaqtrader.com/Trader.aspx?id=shortinterest (Short Interest)
http://www.newratings.com/main/search_result.m?section=search
(Analyst Ratings)
http://www.insidercow.com/history/company.jsp?company=HALO&B1=Search%21
(Insider Transactions)
http://clinicaltrials.gov/ct2/results?term=rhuph20
http://clinicaltrials.gov/ct2/results?term=hyaluronidase+%28human+recombinant%29
(Clinical Trials)
Clinicals & Partners
http://media.corporate-ir.net/media_files/irol/17/175436/120506RocheHalozymePR.pdf
Halozyme and Roche enter agreement for the application of Enhanze, a novel technology to improve drug delivery
http://media.corporate-ir.net/media_files/irol/17/175436/RocheHalozymeSCRIPPresentation.pdf
(Halozyme and Roche presents “Developing and Managing Strategic Alliances” at the SCRIP conference
May 15-16, 2007 Berlin, Germany)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1049931&highlight=
Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
http://www.genengnews.com/news/bnitem.aspx?name=32185399
Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously (Enhanze 3-16-08)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=962993&highlight=
Halozyme and Baxter Expand Global HYLENEX Collaboration
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=IROL-secToc&TOC=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvY29udGVudHMueG1sP2lwYWdlPTU0NDgxMjkmcmVwbz10ZW5r (Feb. 12, 2008 Slide Show Presentation)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1093211&highlight=
Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1117082&highlight=
Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences
Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1130327&highlight=
Halozyme Therapeutics Presents Pre-Clinical Studies on Dermal Remodeling With HTI-501, a Lysosomal Proteinase
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1147853&highlight=
http://www.baxter.com/about_baxter/news_room/news_releases/2008/03-16-08-gammagard_liquid.html
Phase I/II data showed that Enhanze Technology™ enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with Primary Immunodeficiency
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1163612&highlight=Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
Cheetah full ADA presentation
http://www.halozyme.com/images/ADA%202008%20Poster%20legal.pdf
Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1177539&highlight=
Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1170737&highlight=
Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1220870&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1233454&highlight=
Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1234643&highlight=
Halozyme Deprioritizes Bisphosphonate Program to Reallocate Resources to More Commercially Attractive Internal Programs
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1295922&highlight=
Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1240232&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1244971&highlight=
Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1248119&highlight=
AACR presentations show that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1277960&highlight=
Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations |
|
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1293715&highlight=
Accelerated Insulin Pharmacokinetics and Improved Glycemic Control in T1DM Patients by
Coadministration of Prandial Insulin with Recombinant Human Hyaluronidase
http://www.halozyme.com/ADA%202009%20Poster%20v3%202.pdf
Halozyme Announces Roche Selects Fifth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1297519&highlight
Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1307856&highlight=
First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1330295&highlight=
Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration |
Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1, Published Today in Pediatrics |
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1338559&highlight=
Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial with Subcutaneous Herceptin(R)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1344910&highlight=
Earnings Transcripts
http://seekingalpha.com/article/68609-halozyme-therapeutics-q4-2007-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Q4 2007 Earnings Call Transcript
http://seekingalpha.com/article/76655-halozyme-therapeutics-inc-q1-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics Inc. Q1 2008 Earnings Call Transcript
http://seekingalpha.com/article/90080-halozyme-therapeutics-inc-q2-2008-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Inc. Q2 2008 Earnings Call Transcript
http://seekingalpha.com/article/106797-halozyme-therapeutics-inc-q3-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2008 Earnings Call Transcript
http://seekingalpha.com/article/125929-halozyme-therapeutics-inc-q4-2008-earnings-call-transcript?source=trans_sb_previous
Halozyme Therapeutics, Inc. Q4 2008 Earnings Call Transcript
http://seekingalpha.com/article/171883-halozyme-therapeutics-inc-q3-2009-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2009 Earnings Call Transcript
Links to understanding Clinical results
http://www.boomer.org/c/p3/c02/c0210.html
http://health.yahoo.com/other-other/picomoles-per-liter-pmol-l/healthwise--stp1694.html
http://www.unc.edu/~rowlett/units/scales/clinical_data.html
http://www.bio.net/bionet/mm/immuno/2000-July/015983.html
http://www.boomer.org/c/p1/
http://www.merck.com/mmpe/sec20/ch303/ch303a.html
Shares Outstanding: 91,095,288
Float: 73.21M
http://www.deepcapture.com/
(O-T How the market is manipulated and companies destroyed)
Halozyme Therapeutics Inc.
11588 Sorrento Valley Road
Suite 17
San Diego, CA 92121
United States
Phone: 858-794-8889
Halozyme Contact
Robert H. Uhl
Senior Director Investor Relations
858.704.8264
ruhl@halozyme.com
(Disclaimer) Do your own DD and confirm anything said on this board.
Volume: | 2,295,556 |
Day Range: | 59.11 - 60.98 |
Last Trade Time: | 7:17:27 PM EDT |
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